Preoperative Pain and POCD in Elderly Patients

• Conditions: Postoperative Cognitive Dysfunction

• Registration Number: NCT03393676
• Lead Sponsor: RenJi Hospital

Brief Summary

The purpose of this study is to investigate whether preoperative pain is the risk factor of POCD in elder patients.

Detailed Description

Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. The mechanism of POCD is not clear yet and no effective therapy method. In the present study, we conducted a single-center observational prospective cohort trial in elder patients who undergoing hip joint replacement surgery with general anesthesia to test our hypothesis that preoperative chronic pain is one of the risk factors of POCD after major joint replacement surgery.

Study Timeline

• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2018-01-05
• Study First Posted: 2018-01-08
• Study Start: 2018-01-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-08
• Last Update Posted: 2020-03-10
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Elder than 65 years old
2. Speak Chinese Mandarin
3. Those who will undergo major low limb surgery like hemiarthroplasty or total hip arthroplasty with general anesthesia.
4. Signed the inform consent
5. American Society of Anesthesiologists classification I to II

Exclusion Criteria

1. Existing cerebral disease, or have a history of neurological and psychiatric disease including Alzheimer Disease, stroke, epilepsy and psychosis
2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
3. Severe hearing or visual impairment
4. Unwillingness to comply with the protocol or procedures
5. Cannot communicate with Chinese Mandarin
6. Serious pulmonary, heart , liver or renal insufficiency patients
7. Had anesthesia or surgery within the past 30 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
POCD incidence 7 days (or before leaving hospital) after surgery	7 days (or before leaving hospital)	POCD incidence 7 days (or before leaving hospital) after surgery

Secondary Outcome Measures

Name	Time	Method
POCD incidence 2 months after surgery	2 months after surgery	POCD incidence 2 months after surgery

Trial Locations

Locations (2)

Shanghai Ren ji Hospital; 🇨🇳 Shanghai, Shanghai, China

Reni Hospital, Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, Shanghai, China